1. Technical Field of the Invention
The present invention relates to a regimen for the long-term treatment of acne vulgaris.
2. Description of Background and/or Related and/or Prior Art
Acne vulgaris is a common skin disorder that accounts for up to 20% of the visits to a dermatology facility, and affects the majority of the teenage population. Management of acne is challenging, especially when considering the chronicity of the disease and its variability in response to treatment.
The management of acne often requires combination therapy and a long-term therapeutic strategy. (See, for example, Thiboutot D., “New treatments and therapeutic strategies for acne,” Arch. Family. Med., 2000; 9: 179-187; Gollnick H, Cunliffe W, Berson D, et al., “Management of acne, a report from a Global Alliance to Improve Outcomes in Acne,” J. Am. Acad. Dermatol., 2003;49(I suppl):SI-S37). Maintenance therapy is necessary for many acne patients, as acne lesions have been shown to recur after. discontinuing a successful treatment regimen. (See Gollnick H, Cunliffe W, Berson D, et al., “Management of acne, a report from a Global Alliance to Improve Outcomes in Acne,” J. Am. Acad. Dermatol., 2003;49(I suppl):SI-S37; Thielitz A, Helmdach M, Ropke E-M, Gollnick H., “Lipid analysis of follicular casts from cyanoacrylate strips as a new method for studying therapeutic effects of anti-acne agents,” Br. J. Dermatol., 2001;145:19-27).
Despite the variety of medications available for the treatment of acute acne, there are few studies with respect to the safety and efficacy of the long-term treatment of patients with acne vulgaris.
Currently, the most effective comedolytic agents are oral isotretinoin and topical retinoids. (See Cunliffe W J, Holland D B, Clark S M, Stables, G I, “Comedogenesis: some new aetiological, clinical and therapeutic strategies,” Br. J. Dermatol., 2000; 142: 1084-1091). Oral isotretinoin is an impractical choice for long-term therapy due to the potential for toxicity and teratogenicity. Topical anti-acne medication such as retinoids, could be associated with elevated skin irritation, so careful consideration must be given to the tolerability of a potential maintenance therapy. Cutaneous side effects may decrease the likelihood of treatment adherence, particularly when treating an asymptomatic condition. (See Koo J., “How do you foster medication adherence for better acne vulgaris management?” SKINmed., 2003; 2:229-33; and Haider A, Shaw J C., “Treatment of acne vulgaris,” JAMA., 2004;292:726-735).
Adapalene (6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid) is a naphthoic acid derivative with potent retinoid and anti-inflammatory properties. Adapalene was developed for the topical treatment of acne vulgaris and other retinoid-sensitive dermatoses including various disorders of keratinization, proliferation and differentiation. Adapalene acts mainly by regulating differentiation of keratinocytes (comedolytic effect and preventing new comedones), but also has anti-inflammatory activity.
Reported non-serious adverse reactions associated with adapalene include common signs and symptoms of local irritative reactions (erythema, peeling, dry skin, pruritus, burning and stinging), rare cases of local allergic reactions (edema at the application site, contact eczema or dermatitis), or other skin and appendage disorders (very rare cases of hypopigmentation and hyperpigmentation, photosensitivity reactions, hair thinning, hair growth, skin erosion following facial waxing).
However, adapalene and other effective retinoids were studied in short-term (usually 12 weeks) clinical trials. Therefore, need exists to develop a safe and effective method of long-term treatment of acne vulgaris.